Ankle-Brachial Index to Predicte All-Cause and Cardiovascular Mortality in Framingham Risk Score Patients

Adding Ankle Brachial Index to Traditional Framingham Risks Can Improve All-cause Mortality and Cardiac Mortality Prediction in Medium and High Framingham Risk Score Patients: A China Prediction Model

Framingham Risk Score (FRS) included age, gender, body mass index (BMI), cigarette smoking, blood pressure, total cholesterol (TC), LDL-cholesterol (LDL-C) and diabetes mellitus (DM). Previously, Framingham cohort study and other study has confered patients with medium or high FRS had worse prognosis. However, the score list was tending to over-estimate risk in medium FRS or under-estimate risk in high FRS patients . For this reason, ACC/AHA cholesterol guidelines also recommend the use of additional markers to improve atherosclerotic cardiovascular disease (ASCVD) risk assessment and medical decision making.

Meanwhile, the ABI, which was the ratio of systolic pressure at the ankle to that in the arm, was quick, easy and used to diagnosis and assess the severity of peripheral artery disease (PAD) in the legs. Several research have shown its low value as an indicator of general atherosclerosis and independently risk associated with cardiovascular events in prospective studies . In addition, ABI aggressively modified risk factors and accelerated the adverse prognosis of ASCVD. However, whether FRS or ABI, were all related to participants and race. And, most studies were from western countries, lack of Asian date, especially aimed at risk prediction model research. Therefore, this research was aimed to validate incorporating ABI and relevant Framingham risk variables whether could improve prediction all-cause mortality and cardiac mortality in medium and high Framingham risk score (FRS) patients.

Study Overview

• Status: Completed
• Conditions: Ankle Brachial Index

Detailed Description

The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011.

• Study Type: Observational
• Enrollment (Actual): 3687

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

There were 3687 participants from multi-central departments with multiple classical Framingham risk factors atherosclerosis, including 1935 males and 1752 females whose age older than or equal to 18 years. All participants were followed up from November 2011 to June 2018. A total of hospitalized patients were consecutively enrolled from cardiology department and under treatment because of cardiovascular diseases .

Description

The inclusion criteria:

1. Patients were age older than or equal to 18 years
2. Patients with medium and high Framingham risk score，namely, Framingham Risk Score (FRS) 10%-20%,or FRS > 20%.
3. All participants gave written informed consent to this study, which was approved by the ethics committee of Tongji University.

Exclusion Criteria:

1. Patients were suffering from mental illness.
2. Life expectancy of patients were less than 1 year.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ankle-Brachial Index value; Valid participants were separated into 0-0.60, 0.61-0.90, 0.91-0.99, and 1.00-1.40 four ABI subgroups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Causes mortality and Cardiac mortality	In this study, the Cardiac death was only cardiac event death. Medical records and death certificates of all patients who had an event were obtained and validated by cardiologist. Death was confirmed from hospital records or by contact with participants and their families. All materials were reviewed independently by five senior physicians of the cohort study to confirm the cause of death.	from November 2011 to June 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New-onset Cardiovascular Events	New-onset Cardiovascular events are composed of cardiac including non-fatal myocardial infarction, unstable angina, and coronary revascularization procedures during follow-up time. Exclusion criteria were stale angina (>6 months), revascularization procedure for CAD ( >6 months) and myocardial infarction( >6 months).	from November 2011 to June 2018

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2011
• Primary Completion (Actual): March 12, 2013
• Study Completion (Actual): May 10, 2017

Study Registration Dates

• First Submitted: March 13, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Prediction Model; Ankle Brachial Index; Framingham Risk Score; Atherosclerosis risk; All-cause Mortality; Cardiac Mortality
• Other Study ID Numbers: AIRPORTS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No